Observing the Role of Inflammation in Peripheral Artery Disease and Its Impact on Heart and Mobility Health: PANACEA-O. (PANACEA-O)

March 25, 2026 updated by: Cardiology Research UBC

Protocol Title Peripheral Arterial Disease and InflammatioN Study Assessing the Cardiovascular and Functional Effects - Observational Study: PANACEA-O

This registry aims to collect detailed information about people in Canada who have Peripheral Artery Disease (PAD) and are receiving care in heart clinics while still able to walk and live in the community. Researchers want to better understand what these patients are like at the start of their care and looking at their general health, levels of inflammation in their bodies, and how well they can move and function in daily life.

The results of this study will help healthcare providers better understand what PAD looks like in today's Canadian heart clinics. It will also help guide future research studies that focus on inflammation and PAD. The researchers believe that PAD patients can be routinely recruited from these clinics, and that most of these patients will have high levels of inflammation (shown by high blood CRP levels) and poor physical ability when they first join. The findings will show that there is a strong need to regularly check for PAD in heart clinics so that patients can be identified early and offered new treatments in the future and especially treatments that may help reduce inflammation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Peripheral arterial disease is a common manifestation of atherosclerosis that can lead to significant morbidity and mortality. Inflammation plays a key role in the pathogenesis of PAD. Although the pathophysiology of intermittent claudication is attributed primarily to a flow-limiting stenosis or occlusion of a conduit artery that limits oxygen delivery during exercise, a large body of evidence indicates that, with exercise, limb ischemia evokes an acute systemic response characterized by increased oxidative stress, inflammation, and endothelial dysfunction and guidelines recommend smoking cessation and supervised exercise therapy to improve IC, but there are few pharmacologic options.

Cilastozol, a selective and potent phosphodiesterase (PDE) 3A inhibitor and naftidrofuryl, a selective inhibitor of the 5-hydroxytryptamine (serotonin) receptor type 2 (5-HT2), both provide modest benefits on maximum walk distance.(3) However, methodologic inconsistencies, lack of hard objective endpoints, and multiple sources of potential bias in the cited studies supporting their approval have resulted in limited availability and uptake of these agents. While the upcoming STRIDE trial will evaluate the role of semaglutide in improving functional capacity in patients with T2D and PAD, additional strategies need to be evaluated.

The prevalence of PAD in an ambulatory population of patients at risk for this condition is unknown. There currently exists no registry (local or regional) that routinely documents this condition. There are some contemporary registries that exist, but this is mainly among patients with PAD who have already received a revascularization procedure. Furthermore, the prevalence of PAD, inflammation, and functional status is unknown.

The specific aims of this registry are to (1) capture the detailed patient demographic and prevalence of inflammation (i.e., CRP) among PAD patients in an ambulatory population of patients followed in Canadian cardiovascular clinics and (2) determine baseline functional capacity in these PAD patients at baseline with a 6- minute walk distance. The results of this prospective registry can help inform both the landscape of PAD in contemporary Canadian cardiovascular clinics as well as to inform enrollment of future clinical trials in this space targeting inflammation and PAD (i.e., PANACEA). It is hypothesized that PAD patients can be routinely recruited in cardiovascular clinics in Canada, with the vast majority having elevated CRP and relatively poor functional capacity at baseline. The results of this registry will demonstrate the unmet need to routinely screen and identify PAD patients within cardiovascular for future therapies that may be particularly helpful in this population, including those potentially targeting inflammation

The results of this registry have the potential to significantly impact clinical practice guidelines for the management of PAD. By providing robust data on the prevalence of inflammation and its correlation with functional impairment in PAD patients, this registry will underscore the importance of routine screening for PAD in cardiovascular clinics. The identification of patients with elevated CRP and poor functional capacity at baseline will highlight the need for early and targeted interventions, potentially leading to the development of new therapeutic strategies aimed at reducing inflammation and improving outcomes in this high-risk population. Additionally, the registry data may inform the design and enrollment of future clinical trials, contributing to the advancement of evidence-based practices in the management of PAD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Fordyce, MD MHS MSc FRCPC
        • Sub-Investigator:
          • Darryl Wan, MD, FRCPC, RPVI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

PAD patients recruited from Cardiovascular Clinics at Vancouver General Hospital and McGill University Health Centre

Description

Inclusion Criteria:

  • Age >/= 19 years of age
  • Ability to provide informed consent before any trial-related activities

  • Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa meeting all of the following:

    1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview.
    2. Ankle-brachial-index (ABI) equal to or below 0.90 (the leg with lowest index is chosen in case of bilateral disease) or ≥ 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound, or a history of lower extremity revascularization

Exclusion Criteria:

  • Current or previous treatment with any immunomodulating agent within 90 days prior to the day of screening.
  • Walking ability limited by conditions other than PAD
  • Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability).
  • Vascular revascularisation procedure for PAD of any kind 180 days prior to the day of screening.
  • Planned arterial revascularisation known on the day of screening.
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening.
  • Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV.
  • Signs/symptoms of critical limb ischemia (leg gangrene, rest pain, ischemic wounds, etc)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
PAD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test (6MWT)
Time Frame: Baseline visit
Distance in metres walked in 6 minutes as a measure of functional capacity
Baseline visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
High-sensitivity C-reactive Protein (hs-CRP)
Time Frame: Baseline visit
Unit: mg/L
Baseline visit
Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline visit
Unit: %
Baseline visit
VascuQoL-6 Total Score
Time Frame: Baseline visit
Vascular Quality of Life Questionnaire (VascuQoL-6): Each question is scored 1-4.
Baseline visit
Systolic Blood Pressure
Time Frame: Baseline visit
Unit: mmHg
Baseline visit
Heart Rate
Time Frame: Baseline visit
Unit: bpm
Baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardiology Research UBC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Fordyce, MD MHS MSc FRCPC, Vancouver General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H25-00134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The registry data at the end of the registry may lead to the possible design of a larger trial (to calculate the sample size and build data collection instruments).The registry investigator will have access to the de-identified dataset after the end of the registry.

IPD Sharing Time Frame

At the end of the registry for approximately one year.

IPD Sharing Access Criteria

The registry investigator will have access to the de-identified dataset after the end of the registry.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral Vascular Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings